# P170018: LIFEPAK® CR2 Defibrillator

- Pathway: PMA
- Applicant: Physio-Control, Inc.
- Decided: Dec 21, 2018 after 569 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 22, 2025 · Class II · Z-2499-2025: Due to required inspections not being performed on products/units that have gone through servicing.
- Jan 14, 2021 · Class II · Z-1189-2021: Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

Source page: https://510kreport.com/device/P170018
Methodology: https://510kreport.com/methodology